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Histerectomy Vs Partial Myometrial Resection for Placenta Accreta Spectrum

NCT05013749 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-11-25

Study results available
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Summary

Currently, Placenta Accreta Spectrum (PAS) has two treatment options: hysterectomy (completely removing the uterus) and partial myometrial resection (resecting the part of the uterus affected by this pathology).

The present study is a feasibility study of a multicenter, randomized controlled clinical trial to be carried out in 3 health institutions. Patients who meet the inclusion criteria, after signing the informed consent, will be taken to the surgical procedure and before the start of the procedure they will be randomized to one of the two interventions, hysterectomy or partial myometrial resection, intra-surgical clinical outcomes will be explored and a follow-up will be carried out during the immediate post-surgical period (72 hours), in 7 to 12 days and at 42 days postpartum.

A sample size of 60 patients is estimated among the 3 health institutions, with an approximate duration of the study of 24 months.

Conditions

  • Placenta Accreta

Interventions

PROCEDURE

Hysterectomy

Hysterectomy: An incision will be made above the level of the placenta, delivering the newborn. Uterotonics will be administered, and spontaneous delivery of the placenta will be awaited using gentle traction. The absence of spontaneous separation of the placenta will confirm the diagnosis of PAS, the patient will undergo to hysterectomy. The complete removal of the uterus will be attempted, including the cervix, the duration of the intervention and intraoperative blood loss will be recorded, as well as the damage to organs neighboring the uterus. In this arm of the study, to hysterectomy will be performed in 100% of patients

PROCEDURE

Partial Myometrial Resection

Partial myometrial resection: The technique described by Palacios-Jaraquemada et al5. will be followed. Briefly, the uterus will be dissected to free it from the posterior wall of the bladder to the cervix. The vesico-uterine vessels will be ligated and the parametrial space will be visualized. The hysterotomy will be performed in the upper segment, immediately above the area of invasion of the myometrium. The entire invaded myometrium and the entire placenta will be removed. The uterus will repair itself in one or two layers. Intrauterine balloon tamponade will be used if indicated.

Sponsors & Collaborators

  • Fundacion Clinica Valle del Lili

    lead OTHER

Principal Investigators

  • Albaro Nieto-Calvache, MD · Fundacion Clinica Valle del Lili

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-20
Primary Completion
2023-04-17
Completion
2023-04-17

Countries

  • Colombia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05013749 on ClinicalTrials.gov